QUANTA Flash Calprotectin and Fecal Extraction Device
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K180971 FDA 510(k)
- FDA Product Code
- NXO FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.5180 FDA 510(k)
- Regulation Number
- 866.5180 FDA 510(k)
- Advisory Committee
- Immunology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The QUANTA Flash Calprotectin and Fecal Extraction Device is a Fecal Extraction Device (NXO) designed for automated processing of stool samples. It facilitates the extraction of calprotectin, a biomarker used in immunology to assess intestinal inflammation, particularly in conditions such as inflammatory bowel disease. The device eliminates manual stool weighing by integrating a collection stick and extraction buffer within a single-use tube, ensuring consistency and efficiency in sample preparation.
This single-use device is supplied as a sterile tube containing 2.8 mL of extraction buffer and a grooved collection stick. It is intended for use with the QUANTA Flash Calprotectin assay and the BIO-FLASH instrument, enabling direct placement of the processed sample for automated analysis. The device adheres to FDA 510(k) clearance (K180971) and In Vitro Diagnostic Device Directive (IVDD) compliance, with a classification under EU Regulation 866.5180. Storage and handling follow standard aseptic practices for single-use diagnostic devices.
Frequently asked questions
What is the QUANTA Flash Calprotectin and Fecal Extraction Device used for in clinical practice?
This device is designed to automate the processing of stool samples for calprotectin extraction, a biomarker used to evaluate intestinal inflammation in conditions like inflammatory bowel disease. By eliminating manual stool weighing, it ensures consistent and efficient sample preparation, which is critical for accurate immunology testing.
How is the QUANTA Flash Calprotectin and Fecal Extraction Device supplied, and is it reusable?
The device is supplied as a single-use sterile tube containing 2.8 mL of extraction buffer and a grooved collection stick. It is not intended for reuse, adhering to standard aseptic practices for single-use diagnostic devices to maintain sample integrity and prevent contamination.
What instruments or assays is this device compatible with, and how does it streamline the workflow?
The device is specifically designed for use with the QUANTA Flash Calprotectin assay and the BIO-FLASH instrument. Its integrated collection stick and extraction buffer allow direct placement of the processed sample into the BIO-FLASH for automated analysis, reducing manual handling and improving workflow efficiency.
How should the QUANTA Flash Calprotectin and Fecal Extraction Device be stored, and what precautions should be taken?
The device follows standard storage and handling practices for single-use diagnostic devices. It should be stored in a clean, dry environment, protected from contamination, and used within its specified shelf life. Since it is sterile upon packaging, it must remain unopened until use to preserve sterility.
What regulatory pathways has this device undergone, and what does that mean for its use?
The device has received FDA 510(k) clearance (K180971) and complies with the In Vitro Diagnostic Device Directive (IVDD), including classification under EU Regulation 866.5180. This means it has been evaluated for safety, performance, and compliance with regulatory standards, ensuring its suitability for clinical use in immunology testing as intended.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Inova Diagnostics Launches First FDA Cleared Calprotectin Extraction Device, QUANTA Flash Calprotectin and Fecal Extraction Device, PDF Microsoft Word - 510k_Summary QUANTA Flash Calprotectin
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K180971 | Class II | Active |
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Manufacturer
- Manufacturer
- Inova Diagnostics, Inc.
Sources (2)
- FDA 510(k) K180971 24 fields · synced Sep 20, 2026
- EUDAMED 1 fields · synced May 18, 2026